Efficacy of Sublingual Midazolam in Association With Oral Morphine in Children Analgesia After Bone Fracture

NCT00416039 | Completed Phase 3

• 1 other identifier: P051033
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

It is a randomized simple-blind monocentric study; the group A will receive oral morphine with placebo and the group B will receive oral morphine with sublingual midazolam. The aim of this study is to show a more important pain decrease in the group taking midazolam versus placebo.

Conditions

Fractures

Keywords

midazolam; sublingual; oral morphine; children; bone fracture; bone fracture with a deformed member

Outcome Measures

Primary Outcomes (1)

• Difference in the measurement of pain analogical scale values at 30 minutes between the two groups

  after administration until 120 minutes

Secondary Outcomes (7)

• Pain Analogical scale Values at 15, 30 minutes, 1 hour, 1h30 and 2 hours.

  after administration until 120 minutes

• Pain Analogical scale Values after the treatment of the fracture

  after administration until 120 minutes

• Respiratory rate, Oxymetry

  after administration until 120 minutes

• Conscience (lethargy or irritability)

  after administration until 120 minutes

• nausea,

  after administration until 120 minutes

Study Arms (2)

1

EXPERIMENTAL

Midazolam and morphine

Drug: Midazolam

2

PLACEBO COMPARATOR

placebo, Nacl 0.9 %, morphine 0.5 mg/kg

Drug: Placebo

Interventions

Midazolam DRUG

0.2 mg/kg of sublingual midazolam and 0.5 mg/kg of morphine

1

Placebo DRUG

placebo at 0.2 mg/kg and morphine 0.5 mg/kg

2

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children between 5 and 16 years old
• children with a disjoined bone fracture
• children needed oral morphine analgesia
• written informed consent from one or the two parents or legal pad

You may not qualify if:

• ASA score \> 2
• concomitant administration of oral analgesia (level II WHO classification) less than 6 hours
• concomitant administration of benzodiazepine less than 24 hours

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hopital Necker enfants Malade - Department of Pediatric Emergency

Paris, 75015, France

Location

Related Publications (2)

• 21480984

  BACKGROUND

• Wille-Ledon C, Chappuy H, Giraud C, Treluyer JM, Cheron G. Comparison of a morphine and midazolam combination with morphine alone for paediatric displaced fractures: a randomized study. Acta Paediatr. 2011 Nov;100(11):e203-7. doi: 10.1111/j.1651-2227.2011.02311.x. Epub 2011 May 11.

  PMID: 21480984 RESULT

MeSH Terms

Conditions

Fractures, Bone

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Gérard CHERON, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2006
• First Posted: December 27, 2006
• Study Start: January 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: February 1, 2009
• Last Updated: November 20, 2025

Record last verified: 2025-11

Locations

FR (1)